[apinstein]

They went to all the trouble to create a huge trial and didn’t make it double-blind, placebo controlled? That is so suspect. We know how to create good experiments, so I just have little trust in bad experiments, especially at this scale.

I don’t care what the outcome is, treatments are treatments. I have no hope for a particular outcome. It’s just bad science. And I might argue bad faith science.

Potential biases: for instance in Brazil there is a very high level of prior Covid infections. What I’d previously infected people were more likely to opt in to treatment bc they are more afraid of reinfection, and the result came from reduction due to prior immunity? What if people that took the Medecine behaved differently than non-takers?

[nradov]

The authors didn't "create a huge trial". This was just an observational study. While observational studies are less powerful than randomized controlled trials they're not necessarily bad science. Much of our current knowledge in other areas of medicine came from observational studies.

While this study is rather weak and doesn't give us any really definitive results it is a useful data point that can be rolled into future meta analyses.

[apinstein]

Are you sure?

> Results: Of the 223,128 citizens of Itajaí considered for the study, a total of 159,561 subjects were included in the analysis: 113,845 (71.3%) regular ivermectin users and 45,716 (23.3%) non-users.

That reads to me like 160k people participated, and 113k optionally choose to take Ivermectin as prophylaxis.

Am I missing something ?

[incrudible]

I'm inclined to agree, but I must ask: Would you have the same standards when it comes to the vaccines?

I'm not aware of any double-blind placebo-controlled trial that is powerful enough to determine risk reduction for death or severe disease in vaccines, much less over several months.

[iandanforth]

I'm not sure I understand your statement https://www.nejm.org/doi/full/10.1056/nejmoa2035389 showed an absurdly large effect in a controlled blinded trial which was at least part of the reason emergency approval was granted.

[incrudible]

Yes, we did observe a large effect within the first months in an immunocompetent middle-aged population, but as we all know now, that effect doesn't last very long. The placebo group has been unblinded and vaccinated, so we wouldn't know how they fared in the long run.

[acdha]

> but as we all know now, that effect doesn't last very long.

What, precisely, do you think we know? The vaccines were tested against the first strain so it's not surprising that they lost effectiveness at preventing infection entirely against variants like Omicron with significantly greater immune evasion but even there we still see massive benefits against severe cases. The current performance of the mRNA vaccines against Omicron is still better than many people cautioned would considered a good result for the first iteration of a vaccine created for a new virus.

[incrudible]

Consistent waning of efficacy against infection over time has been observed regardless of variants[1].

At the same time, we didn't see "massive benefit" against severe cases in breakthrough infections in a matched cohort study[2]. This leads me to suspect that current statistical observations do not reflect reality and may well be artifacts. Paradoxically, we're also observing increased odds of Omikron infection after (two dose) vaccination.

Furthermore, we're administering boosters even to teenagers based on good faith, not good science. Hence, there still is a need for placebo-controlled trials.

[1] https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3949410

[2] https://www.medrxiv.org/content/10.1101/2021.10.26.21265508v...

[mike00632]

New study out today shows that COVID vaccines reduce the risk of death from Omicron by 95%.

https://www.wsj.com/articles/covid-19-vaccine-booster-shot-c...

[cloutchaser]

As far as I know this was explained away with - it's too urgent and it's not ethical to have placebo controlled vaccine trials at this time, since everyone will contract covid. So we didn't have any.

[rsfern]

The clinical trials were placebo controlled, see the sibling comment for a reference to the results, or look up the protocols on clinicaltrials.gov

[ericb]

The vaccine studies were placebo controlled.

[incrudible]

The trials are ongoing, but the placebo group has long been vaccinated.

[jlbooker]

The trials lasted long enough to gather the statistical evidence needed to show that the vaccine prevented the trial group from becoming infected (and that it was highly unlikely the trial group did better due to random chance). When that point was reached, the trial was deemed sufficient and was ended/unblinded. When people are dying by the thousands every day (in the USA alone), how much longer would you have wanted the trial to go on? We found out what we wanted to know. The vaccine worked. There's no need to carry on and ask the placebo group to continue with the risk of being infected.

[incrudible]

I'm not going to argue the ethics, I'm going to argue that these trials are under-powered and insufficient to make bold claims about vaccine efficacy. The trials are in fact not completed until the end of the year, but there is little further information to be gained after dissolution of the placebo group.

Remember, the people defending Ivermectin also argue that it's unethical to do further trials when it is "clearly effective" (according to under-powered studies). Consider that pharma companies deliberately avoid follow-up trials to avoid finding results that don't align with business interest. Remdesivir and Molnupiravir both looked promising in early trials, but were found to be rather ineffective (and dangerous) in later trials.

I don't have a problem with administering drugs/vaccines based on good faith and speculative benefit if that is declared appropriately. Just don't dress it up as "scientifically validated".

[Vrondi]

One of the things that has made it hard to believe the drug companies behind the new vaccines are trustworthy is the way that they and the medical establishment has continuously claimed that these vaccines have good long-term safety, when long-term safety wasn't even something that was being tested for, and a long term hasn't yet elapsed. Such claims were being spouted by government and medical people even before the EUA was finalized, which makes the entire thing seem quite untrustworthy to anyone who was looking at the actual situation and research.

[incrudible]

An all-too-convenient excuse, considering how many people now willingly put themselves into the control group called "anti-vaxxer".